Reported Aug 19, 2020 · Ongoing
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also…
Linet Americas
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Linet Americas · 10420 Harris Oak Blvd · Charlotte, NC · 28269-7517
Is this the product you have?
- AVE 2 Birthing Bed - Product Usageis designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 4BCPPB-3XCZ0002(Lot Numbers PPB1155 - PPB1174, PPB1194 - PPB1213, PPB1222 - PPB1241, PPB1265 - PPB1284, PPB1292 - PPB1311, PPB1346 - PPB1365, PPB1375 - PPB1394, PPB1451 - PPB1466, PPB1477 - PPB1496, PPB1508 - PPB1527) 4BCPPB-CCZ0008Lot Number PPB1446 - PPB1449 4BCPPB-BCZ0009Lot Number PPB1541 - PPB1542 - Amount recalled
- 202 devices
Where it was sold
Why it was recalled
The UDI on the device label indicates incorrect manufacturer.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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